MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7214
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter removal difficulty and shaft break occurred.The target lesion was located in a femoroperoneal graft.Following stent deployment, a 2.50mm x 20mm nc emerge balloon catheter was advanced for post-dilatation.However, upon removal of the balloon, resistance was encountered.Once the device was removed, it became apparent that the balloon had separated from the shaft at the connection of the shaft and balloon portion.The balloon portion that was left in the periphery was removed with a snare.No further patient complications were reported and no harm was done to the patient.Returned product consisted of a nc emerge balloon catheter,.014" guidewire, and a snare device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks on the shaft.The shaft and guidewire lumen is separated approximately 126.4cm from the hub.Microscopic examination revealed a tear on the shaft from the exit notch to the separation.From the exit notch to the separation also appears to have been stretched prior to separation.The guide wire used in the clinical procedure was returned with the device so it was used for functional testing.The returned guidewire measured.014" so it is within specification.When advancing the balloon onto the guidewire there was no resistance felt.When attempting to remove the balloon from the guidewire, the guidewire lumen would buckle at the separation making removal hard.As to not create permanent buckling on the guidewire lumen the device was removed by advancing it through the entire guidewire.The guidewire lumen may have buckled during the clinical trial causing the difficulty to remove.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8132495
• Report Number: 2134265-2018-63440
• Device Sequence Number: 16533225
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0022763638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention